NCT02276755

Vitamin D Supplementation in TB Prevention

Vitamin D in TB Prevention in School Age Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,851 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to determine whether vitamin D supplementation reduces risk of acquiring latent tuberculosis infection (LTBI) in school age children in Mongolia. The investigators hypothesize that (1) vitamin D supplementation will reduce risk of acquisition of LTBI, (2) vitamin D supplementation will safely reduce risk of developing active TB and improve other secondary efficacy outcomes, and (3) children with the lowest vitamin D status at baseline will gain most from the intervention.

Conditions

• Latent Tuberculosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol (vitamin D3)	14000 IU vitamin D3 weekly Experimental group will receive vitamin D supplement (Tishcon, USA).
OTHER	Placebo	Placebo group will receive placebo (Tishcon, USA) weekly.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-06-01
• Completion: 2020-06-01
• First posted: 2014-10-28
• Last updated: 2020-07-16

Locations

1 site across 1 country: Mongolia